MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that, following intraocular les (iol implant procedure, the posterior capsular rupture occurred when i/a performing after the iol was inserted into the capsule bag.The lens was replaced and the procedure was completed fixing the sclera.The lens was cut in half in the eye and removed it.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case inside the opened carton.Viscoelastic was dried on the lens.One haptic was torn in the gusset area.No other damage observed.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.Information stated the pc tear occurred during the irrigation/aspiration (i/a) after the lens was implanted.A malfunction was not indicated against the iol.The lens was cut in half in the eye and removed it.Based on the evaluation of the returned lens, the translated description of "the lens was cut in half in the eye and removed it" was referring to the damage to the one haptic to remove the lens from the eye.There have been no other complaints in this lot.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14495435
• Report Number: 1119421-2022-01120
• Device Sequence Number: 6150294
• Product Code: POE
• UDI-Device Identifier: 00380652421164
• UDI-Public: 00380652421164
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2026
• Device Model Number: DFT015
• Device Lot Number: 15173295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 07/31/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown